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New treatment option for Gastric Adenocarcinoma
Official title Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer
ClinicalTrials.gov ID: NCT03161522
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric adenocarcinoma.
Also referred to as Ro 09-1978/000, Xeloda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies how well chemotherapy with or without radiation or surgery works in treating participants with esophageal or gastric cancer that has spread to less than 3 places in the body (oligometastatic). Drugs used in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- The patient has a pathologic diagnosis of tumor biopsy or FNA of esophageal or gastric cancer of adenocarcinoma histology
- The patient is staged with EGD and PET/CT scan.
- The patient has three or less observable metastatic lesions. Patients may have three or less radiographically visible metastatic lesions at diagnosis...
- The patient has three or less observable metastatic lesions by diagnostic scans (CT scan, PET/CT, eEndoscopic ultrasound, MRI, or bone scan)...
- Osseous metastases or visceral metastases will each count as one metastatic site.
You likely can't join if
- Patients with prior chemotherapy or radiation therapy for their diagnosis of esophageal or gastric cancer. Patients with prior radiation therapy to...
- Patients with fistula documented radiographically or by EDG/EUS, EBUS.
- Patients with life expectancy less than 6 months, ECOG \>3
- Female patients who are pregnant confirmed by bHCG lab test.
- Patient has history of uncontrolled angina, congestive heart failure or recent MI within 6 months.
- Nursing females
See the full eligibility criteria
- The patient has a pathologic diagnosis of tumor biopsy or FNA of esophageal or gastric cancer of adenocarcinoma histology
- The patient is staged with EGD and PET/CT scan.
- The patient has three or less observable metastatic lesions. Patients may have three or less radiographically visible metastatic lesions at diagnosis or if have regressed to three or less metastatic lesions after...
- The patient has three or less observable metastatic lesions by diagnostic scans (CT scan, PET/CT, eEndoscopic ultrasound, MRI, or bone scan). Metastatic lesions include distant M1 lymph node group; which will be counted...
- Osseous metastases or visceral metastases will each count as one metastatic site.
- Each CNS metastases will count as one metastatic site.
- Satellite lesions in the primary esophageal malignancy such as skipped esophageal primaries are not considered metastatic sites. Symptomatic metastatic sites can be treated locally prior to randomization or by...
- Symptomatic metastatic sites may be treated with radiation or surgery prior to enrollment.
- Patient ECOG of 0-2, with life expectancy of at least 6 months
- Patients age \>18 yrs old but \<80 yrs old and signed informed consent
- Women of child-bearing age must have pregnancy test at time of enrollment, agree to use of adequate contraception (birth control hormone or barrier method) for the duration of the study and for six months after...
- Patients with prior chemotherapy or radiation therapy for their diagnosis of esophageal or gastric cancer. Patients with prior radiation therapy to same site for another diagnosis of cancer. Note: Patients may receive...
- Patients with fistula documented radiographically or by EDG/EUS, EBUS.
- Patients with life expectancy less than 6 months, ECOG \>3
- Female patients who are pregnant confirmed by bHCG lab test.
- Patient has history of uncontrolled angina, congestive heart failure or recent MI within 6 months.
- Nursing females
- Patients in poor nutritional state
- Patients with:
- Severely depressed bone marrow function
- Potentially serious infections
- Known hypersensitivity to 5-fluorouracil
- Known or suspected to have a dihydropyrimidine dehydrogenase deficiency (as these patients are at a greater risk of experiencing symptoms of toxicity)
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.